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EC number: 272-911-3 | CAS number: 68920-03-6 A complex combination obtained by steam distillation of C16-18 and C18-unsatd. glycerides followed by condensation of the steam.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source (documentation insufficient for assessment)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A modified Draize test was conducted to evaluate skin irritation and sensitization potential of palm oil (15%) in human. During induction, the test substance was applied occlusively to skin sites using a Finn Chamber. Total of 10 inductions applications were made to each subject for 3 consecutive wks. Induction reactions were scored 48 and 72 h post application according to following scoring system: 0 (no reaction) to 4 (erythema, edema and bullae). After 12 d of rest, an occlusive challenge patch was applied to a new site. Challenge patches were remained in place for 48 h. Reactions were scored at 48 and 96 h post application.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd.
- EC Number:
- 266-948-4
- EC Name:
- Glycerides, C16-18 and C18-unsatd.
- Cas Number:
- 67701-30-8
- Molecular formula:
- No generic molecular formula is available
- IUPAC Name:
- Glycerides, C16-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Palm oil (CAS N° 8002-75-3, EC N° 232-316-1). Under the SDA nomenclature, the name of this substance is 'Glycerides, C16-18 and C18-unsatd.'
- Substance type: Triglycerides of vegetable origin
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 88 females and 22 males
- Age: 20-76 yrs - Clinical history:
- Not applicable
- Controls:
- Not applicable
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn Chamber
- Vehicle / solvent: petrolatum
- Concentrations: 15%
- Amount applied: 0.025 g
- Frequency of application: 3 applications per wk for total of 10 induction applications followed by challenge application (after 12 d of rest)
- Scoring system: 0 (no reaction) to 4 (erythema, edema and bullae)
- Scoring frequency: 48 and 72 h post application in induction phase and 48 and 96 h post application in challenge phase
Results and discussion
- Results of examinations:
- Palm oil did not induce sensitization in the 110 subjects studied.
Details:
- Number of subjects with positive reactions: 3 (score = 1) during the induction but no reactions in the challenge phase
- Number of subjects with negative reactions: 107
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, 15% of the test substance did not induce sensitization in humans.
- Executive summary:
A study was conducted to evaluate skin irritation and sensitization potential of ‘glycerides, C16-18 and C18-unsatd.’ (as 15% palm oil) in human.
During induction, the test substance was applied occlusively to skin sites on the scapular region of the back of 110 subjects using a Finn Chamber. Total of 10 inductions applications were made to each subject for 3 consecutive wks. Induction reactions were scored 48 and 72 h post application according to modified Draize method. After 12 d of rest, an occlusive challenge patch was applied to a new site in the scapular region. Challenge patches were remained in place for 48 h. Reactions were scored at 48 and 96 h post application.
Reactions (score = 1) were observed in three subjects during induction, and no reactions were observed during the challenge phase.
Under the test conditions, 15% of the test substance did not induce sensitization in humans.
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